Sr. Director/Director, Clinical Operation
Adagene Inc. is looking for an energetic and talented individual to join its multidisciplinary research and development team.
The Senior Director (SD)/Director, Clinical Operations is responsible for the strategic planning, oversight and execution of assigned clinical trials across programs. S/he will make operational strategies and/or decisions in support of achieving clinical program objectives.
The SD/D of Clinical Operations may also directly manage studies. Responsibilities include creating timelines and budgets, overseeing day-to-day operations, ensuring studies are conducted in accordance with regulatory requirements and within established timelines and budgets. Additionally, this person will be responsible for managing relationships with investigator sites, vendors and consultants. He/She will supervise the US Clinical Trial Team and external consultants.
This position also provides an opportunity to join a growing development organization and contribute substantially to how the company will operationalize oncology trials in the future, while expanding internationally.
The candidate must have the ability to work independently, be an effective leader, and an engaged team member in a dynamic, fast-paced environment.
- Provides leadership and therapeutic expertise for the successful operational management of international clinical trials and contributes to the strategic implementation of a clinical development program(s)
- Lead sponsor study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets.
- Ensure effective project plans are in place and operational for each trial and proactively manage project level operational aspects of Clinical Trial Team including management of trial timeline, budget, quality, resources, vendors and risk mitigation.
- Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team
- Oversees the trials, manages responsible study(ies) within agreed timelines and budget and in accordance with internal SOP’s and GCPs
- Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures.
- Participates in the preparation, review and finalization of clinical study-related documents such as protocols, protocol amendments, Clinical Study Reports (CSRs), regulatory submissions, and other publications as required.
- Effectively solves problems and uses judgment relating to national and international regulations, guidelines, investigator interactions and timelines
- Recruits, hires, mentors and manages CTM/CPM direct reports and supports their professional development
Degree: Master is required, a MBA, MPH or similar is strongly preferred.
Major: Clinical Medicine or health related field is required.
- Good Clinical Practice, and clinical trials is essential.
- 5 years of global/Europe trial management experience in Oncology.
- Minimum of 20 years of clinical research administration experience, with eight (8) years at a manager level.
- Experience in establishing the required SOPs for clinical operations.
- Experience in designing global clinical trial plans, organizing global clinical trials, and writing summary reports independently.
Knowledge and Skills:
- Knowledge about research administration, experience with investigator initiated trials.
- Substantial knowledge and understanding of federal regulations affecting clinical trials and medical research is preferred.
- Knowledge of and experience in experimental design, and basic understanding of statistics and statistical methods is required.
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
- Good therapeutic and protocol knowledge.
- Strong knowledge of clinical research financial parameters and project financial tracking and accounting methods.
- Effective presentation skills.
- Strong communication and interpersonal skills, including good command of English language.
- Have demonstrated leadership ability and be flexible and adaptable to changing conditions.
- Strong project planning, leadership, negotiation and presentation skills as well as an ability to contribute creative yet practical solutions to problems.
- Well-connected with key experts and KOLs in the field is preferred.
- Ability to establish and maintain effective working relationships with coworkers, managers and CROs.
- Ability to forge cross-functional working relationships with internal teams and external project partners.
- Ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of trials and resolve issues in a timely fashion.